Johnson and Johnson fined for fraud with Risperdal! Story copied below in case link stops working.
Johnson&Johnson fined $2.2 billion for faulty drug claims,
Updated Tue 5 Nov 2013, 12:19am
Global healthcare giant Johnson & Johnson (J&J) has agreed to pay more than $US2.2 billion to settle allegations of fraudulently
marketing drugs and paying kickbacks to promote their sales.
In one of the largest healthcare fraud settlements in US history, J&J’s criminal and civil fine covers allegations the company marketed
schizophrenia drug Risperdal and other prescription drugs for uses not approved as safe and effective by the Food and Drug
Administration (FDA), the Justice Department said.
The settlement further covers kickbacks allegedly paid to physicians and pharmacies for prescribing and promoting those drugs by J&J.
The actions resulted in millions of dollars in benefits paid by Medicaid, the government healthinsurance program for lowincome and
disabled people, causing losses to both the federal and state governments.
“This global settlement resolves multiple investigations involving the antipsychotic drugs Risperdal and Invega as well as the heart drug
Natrecor and other Johnson & Johnson products,” attorneygeneral Eric Holder said in a statement.
“The settlement also addresses allegations of conduct that recklessly put at risk the health of some of the most vulnerable members of our
society including young children, the elderly, and the disabled.”
Under federal law, pharmaceutical companies only are allowed to market drugs for purposes approved by the FDA.
J&J is to pay $US485 million in criminal fines and forfeiture and a total of $US1.72 billion in civil settlements with the federal government
and the states.
J&J unit Janssen Pharmaceuticals pleaded guilty to the criminal charge of interstate promotion of Risperdal for unapproved treatment of
elderly dementia patients and will pay a total of $US400 million, including a criminal fine of $US334 million and forfeiture of $US66 million.
Janssen’s guilty plea requires approval by the US district court.
Settlement over antipsychotic drug
Settlement over antipsychotic drug
In separately filed civil complaints, the government alleged that J&J and Janssen promoted Risperdal and Invega, a newer antipsychotic
drug, to doctors and to nursing homes as a way to control behavioural disturbances in elderly dementia patients, children, and the
Janssen knew that Risperdal posed serious health risks for the elderly, including an increased risk of strokes, and for children, including
the risk of elevated levels of prolactin, a hormone that can stimulate breast development and milk production, according to the complaints.
The civil settlement also resolves allegations that J&J and Janssen paid kickbacks to Omnicare, the nation’s largest pharmacy specializing
in dispensing drugs to nursing home patients.
In 2009, Omnicare paid $US98 million to resolve its civil liability for claims that it accepted kickbacks from J&J and Janssen.
In addition, the civil settlement announced Monday resolved allegations that J&J and another subsidiary, Scios, caused false claims to be
submitted to federal healthcare programs for the heart failure drug Natrecor.
Scios allegedly marketed the drug for offlabel uses. Intended for patients with severe heart failure, it was given to patients with less
severe heart issues over weeks and months.
As part of the global settlement, J&J must undertake a major overhaul of its pharmaceutical business over five years supervised by the
Health and Human Services inspector general.
Topics: corruption, fraudandcorporatecrime, health, companynews, businesseconomicsandfinance, courtsandtrials, lawcrimeandjustice,
First posted Mon 4 Nov 2013, 6:36pm